An observational study in Opioid Use Disorder, Substance-Related Disorders and Pregnancy Related, sponsored by Senthil Sadhasivam. Enrolling by invitation at 2 sites in United States. Open to female participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Senthil Sadhasivam · Observational
The goal of this observational study is to learn about the long term effects of prenatal opioid exposure. The main objectives are:
In this study participants will:
Any woman of the age of 18 or older that is having a single pregnancy, and currently taking buprenorphine or methadone for opioid use disorder.
Pregnant women with opioid use disorder
Inclusion Criteria:
Exclusion Criteria:
Infants with prenatal opioid exposure:
Inclusion:
Exclusion:
Major congenital anomalies or genetic syndromes affecting neurodevelopment
Control Pregnant Women:
Inclusion:
Exclusion:
Control infants:
Inclusion:
Born to control pregnant mother enrolled in study
Exclusion:
Any major congenital anomalies, genetic abnormalities, neurologic abnormalities, syndromes, or chronic medical conditions affecting neurodevelopment.
150 pregnant mothers with opioid use disorder who are on buprenorphine or methadone treatment
Drug: Buprenorphine or Methadone Treatment · Diagnostic Test: Fetal and Placental MRI · Behavioral: Child Developmental Assessment · Behavioral: Questionnaires · Other: Blood and Placental Samples
100 pregnant mother who to not have a history of opioid use disorder
Diagnostic Test: Fetal and Placental MRI · Behavioral: Child Developmental Assessment · Behavioral: Questionnaires · Other: Blood and Placental Samples
Pregnant mothers must be taking Buprenorphine or Methadone
Two MRIs : * Second Trimester * Third Trimester
At 1 year of life child will receive a developmental assessment
Participants will answer questionnaires on their medical history, pregnancy, substance use, and after birth: their child's development
At each MRI visit a blood sample will be collected for substances, DNA, RNA, epigenetics, and placental biomarkers. At delivery: A sample of placenta will be collected for RNA, DNA, and epigenetic analysis.
Alterations in fetal brain volume
Comparing changes in fetal brain volume using MRI between babies who have had prenatal opioid exposure (POE) and controls
Time frame: Between 20 weeks gestation and delivery
Differences in placenta signal
Comparing differences in placenta signal using MRI between the POE group and controls
Time frame: Between 20 weeks gestation and delivery
Placental epigenetic changes related to POE
Compare placental DNA methylation in POE group and control group
Time frame: Between 20 weeks gestation and delivery
Placental dysfunction biomarkers related to POE
Compare concentrations of blood proteins in POE group vs controls
Time frame: Between 20 weeks gestation and delivery
Neonatal Opioid Withdrawal Syndrome (NOWS) severity
Measuring NOWs severity in the POE group using eat sleep console scores
Time frame: After birth through one year of life
Length of Hospital Stay
Measuring NOWs severity in the POE group using length of hospital stay
Time frame: After birth through one year of life
Ages and Stages Questionnaire Scores during infancy
Comparing neurodevelopment of POE group and controls using the ages and stages questionnaire at multiple time points in baby's first year of life. This questionnaire assesses infants developmental level. Scores can identify whether child is below cutoff and needs professional intervention, close to cutoff and requires more developmental support and learning, or above cutoff and on track.
Time frame: After birth through one year of life
Neurocognitive and behavioral development assessment (Bayley-4) at one year of age
Comparing neurodevelopment of POE group and controls using the Bayley's 4 assessment at one year of age. This assessment is administered by professionals to identify development delays in children.
Time frame: After birth through one year of life
Plan to share: Undecided
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Senthil Sadhasivam